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PAMELOR
Overview
What is PAMELOR?
Pamelor™ (nortriptyline HCl) is 1-propanamine, 3-(10,11-dihydro--dibenzo[] cyclohepten-5-ylidene)--methyl-, hydrochloride.
The structural formula is as follows:
What does PAMELOR look like?
What are the available doses of PAMELOR?
Sorry No records found.
What should I talk to my health care provider before I take PAMELOR?
Sorry No records found
How should I use PAMELOR?
Pamelor™ (nortriptyline HCl) is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.
Pamelor is not recommended for children.
Pamelor is administered orally in the form of capsules. Lower than usual dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients than for hospitalized patients who will be under close supervision. The physician should initiate dosage at a low level and increase it gradually, noting carefully the clinical response and any evidence of intolerance. Following remission, maintenance medication may be required for a longer period of time at the lowest dose that will maintain remission.
If a patient develops minor side effects, the dosage should be reduced. The drug should be discontinued promptly if adverse effects of a serious nature or allergic manifestations occur.
What interacts with PAMELOR?
Monoamine Oxidase Inhibitors (MAOIs)
The use of MAOIs intended to treat psychiatric disorders with Pamelor or within 14 days of stopping treatment with Pamelor is contraindicated because of an increased risk of serotonin syndrome. The use of Pamelor within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated ( ).
Starting Pamelor in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome ( ).
Hypersensitivity to Tricyclic Antidepressants
Cross-sensitivity between Pamelor and other dibenzazepines is a possibility.
Myocardial Infarction
Pamelor is contraindicated during the acute recovery period after myocardial infarction.
What are the warnings of PAMELOR?
Clinical Worsening and Suicide Risk
Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older.
The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs. placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in .
No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.
It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.
All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.
Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.
Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers.
| <18 | 14 additional cases |
| 18-24 | 5 additional cases |
| 25-64 | 1 fewer case |
| ≥65 | 6 fewer cases |
Screening Patients for Bipolar Disorder –
Patients with cardiovascular disease should be given Pamelor only under close supervision because of the tendency of the drug to produce sinus tachycardia and to prolong the conduction time. Myocardial infarction, arrhythmia, and strokes have occurred. The antihypertensive action of guanethidine and similar agents may be blocked. Because of its anticholinergic activity, Pamelor should be used with great caution in patients who have a history of urinary retention. Patients with a history of seizures should be followed closely when Pamelor is administered, inasmuch as this drug is known to lower the convulsive threshold. Great care is required if Pamelor is given to hyperthyroid patients or to those receiving thyroid medication, since cardiac arrhythmias may develop.
Pamelor may impair the mental and/or physical abilities required for the performance of hazardous tasks, such as operating machinery or driving a car; therefore, the patient should be warned accordingly.
Excessive consumption of alcohol in combination with nortriptyline therapy may have a potentiating effect, which may lead to the danger of increased suicidal attempts or overdosage, especially in patients with histories of emotional disturbances or suicidal ideation.
The concomitant administration of quinidine and nortriptyline may result in a significantly longer plasma half-life, higher AUC, and lower clearance of nortriptyline.
Serotonin Syndrome
The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including Pamelor, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular changes (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome.
The concomitant use of Pamelor with MAOIs intended to treat psychiatric disorders is contraindicated. Pamelor should also not be started in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue. All reports with methylene blue that provided information on the route of administration involved intravenous administration in the dose range of 1 mg/kg to 8 mg/kg. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection) or at lower doses. There may be circumstances when it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking Pamelor. Pamelor should be discontinued before initiating treatment with the MAOI ( ).
If concomitant use of Pamelor with other serotonergic drugs, including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, and St. John’s Wort is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.
Treatment with Pamelor and any concomitant serotonergic agents should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated.
Unmasking of Brugada Syndrome
There have been postmarketing reports of a possible association between treatment with Pamelor and the unmasking of Brugada syndrome. Brugada syndrome is a disorder characterized by syncope, abnormal electrocardiographic (ECG) findings, and a risk of sudden death. Pamelor should generally be avoided in patients with Brugada syndrome or those suspected of having Brugada syndrome.
Angle-Closure Glaucoma
The pupillary dilation that occurs following use of many antidepressant drugs including Pamelor may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
Use in Pregnancy
Safe use of Pamelor during pregnancy and lactation has not been established; therefore, when the drug is administered to pregnant patients, nursing mothers, or women of childbearing potential, the potential benefits must be weighed against the possible hazards. Animal reproduction studies have yielded inconclusive results.
What are the precautions of PAMELOR?
Information for Patients
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with nortriptyline hydrochloride and should counsel them in its appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions” is available for nortriptyline hydrochloride. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking nortriptyline hydrochloride.
Clinical Worsening and Suicide Risk –
The use of Pamelor in schizophrenic patients may result in an exacerbation of the psychosis or may activate latent schizophrenic symptoms. If the drug is given to overactive or agitated patients, increased anxiety and agitation may occur. In manic-depressive patients, Pamelor may cause symptoms of the manic phase to emerge.
Troublesome patient hostility may be aroused by the use of Pamelor. Epileptiform seizures may accompany its administration, as is true of other drugs of its class.
When it is essential, the drug may be administered with electroconvulsive therapy, although the hazards may be increased. Discontinue the drug for several days, if possible, prior to elective surgery.
The possibility of a suicidal attempt by a depressed patient remains after the initiation of treatment; in this regard, it is important that the least possible quantity of drug be dispensed at any given time.
Both elevation and lowering of blood sugar levels have been reported.
Patients should be advised that taking Pamelor can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible.
Drug Interactions
Administration of reserpine during therapy with a tricyclic antidepressant has been shown to produce a “stimulating” effect in some depressed patients.
Close supervision and careful adjustment of the dosage are required when Pamelor is used with other anticholinergic drugs and sympathomimetic drugs.
Concurrent administration of cimetidine and tricyclic antidepressants can produce clinically significant increases in the plasma concentrations of the tricyclic antidepressant. The patient should be informed that the response to alcohol may be exaggerated.
A case of significant hypoglycemia has been reported in a type II diabetic patient maintained on chlorpropamide (250 mg/day), after the addition of nortriptyline (125 mg/day).
Drugs Metabolized by P450 2D6 –
In addition, certain drugs inhibit the activity of this isozyme and make normal metabolizers resemble poor metabolizers. An individual who is stable on a given dose of TCA may become abruptly toxic when given one of these inhibiting drugs as concomitant therapy. The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the Type 1C antiarrhythmics propafenone and flecainide). While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition. The extent to which SSRI TCA interactions may pose clinical problems will depend on the degree of inhibition and the pharmacokinetics of the SSRI involved. Nevertheless, caution is indicated in the co-administration of TCAs with any of the SSRIs and also in switching from one class to the other. Of particular importance, sufficient time must elapse before initiating TCA treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary).
Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. Furthermore, whenever one of these other drugs is withdrawn from co-therapy, an increased dose of tricyclic antidepressant may be required. It is desirable to monitor TCA plasma levels whenever a TCA is going to be co-administered with another drug known to be an inhibitor of P450 2D6.
Monoamine Oxidase Inhibitors (MAOIs)
(
,
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Serotonergic Drugs
(
,
.)
Pediatric Use
Safety and effectiveness in the pediatric population have not been established (
). Anyone considering the use of nortriptyline hydrochloride in a child or adolescent must balance the potential risks with the clinical need.
Geriatric Use
Clinical studies of Pamelor did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience indicates that, as with other tricyclic antidepressants, hepatic adverse events (characterized mainly by jaundice and elevated liver enzymes) are observed very rarely in geriatric patients and deaths associated with cholestatic liver damage have been reported in isolated instances. Cardiovascular function, particularly arrhythmias and fluctuations in blood pressure, should be monitored. There have also been reports of confusional states following tricyclic antidepressant administration in the elderly. Higher plasma concentrations of the active nortriptyline metabolite, 10-hydroxynortriptyline, have also been reported in elderly patients. As with other tricyclic antidepressants, dose selection for an elderly patient should usually be limited to the smallest effective total daily dose (
).
What are the side effects of PAMELOR?
Note –
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Cardiovascular –
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Psychiatric –
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Neurologic –
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Anticholinergic –
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Allergic –
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Hematologic –
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Gastrointestinal –
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Endocrine –
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Withdrawal Symptoms –
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Postmarketing Experience
The following adverse drug reaction has been reported during post-approval use of Pamelor. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate frequency.
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Eye Disorders
What should I look out for while using PAMELOR?
Monoamine Oxidase Inhibitors (MAOIs)
The use of MAOIs intended to treat psychiatric disorders with Pamelor or within 14 days of stopping treatment with Pamelor is contraindicated because of an increased risk of serotonin syndrome. The use of Pamelor within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (
).
Starting Pamelor in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (
).
Hypersensitivity to Tricyclic Antidepressants
Cross-sensitivity between Pamelor and other dibenzazepines is a possibility.
Myocardial Infarction
Pamelor is contraindicated during the acute recovery period after myocardial infarction.
What might happen if I take too much PAMELOR?
Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including alcohol) is common in deliberate tricyclic antidepressant overdose. As the management is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. Signs and symptoms of toxicity develop rapidly after tricyclic antidepressant overdose, therefore, hospital monitoring is required as soon as possible.
How should I store and handle PAMELOR?
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in tight container (USP) with a child-resistant closure.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo, and other brands are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured by:Patheon Inc.Whitby, Ontario, CanadaL1N 5Z5Manufactured for:SpecGx LLCWebster Groves, MO 63119 USA Rev 08/2017 Mallinckrodt™ Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in tight container (USP) with a child-resistant closure.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo, and other brands are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured by:Patheon Inc.Whitby, Ontario, CanadaL1N 5Z5Manufactured for:SpecGx LLCWebster Groves, MO 63119 USA Rev 08/2017 Mallinckrodt™ Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in tight container (USP) with a child-resistant closure.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo, and other brands are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured by:Patheon Inc.Whitby, Ontario, CanadaL1N 5Z5Manufactured for:SpecGx LLCWebster Groves, MO 63119 USA Rev 08/2017 Mallinckrodt™ Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in tight container (USP) with a child-resistant closure.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo, and other brands are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured by:Patheon Inc.Whitby, Ontario, CanadaL1N 5Z5Manufactured for:SpecGx LLCWebster Groves, MO 63119 USA Rev 08/2017 Mallinckrodt™ Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in tight container (USP) with a child-resistant closure.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo, and other brands are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured by:Patheon Inc.Whitby, Ontario, CanadaL1N 5Z5Manufactured for:SpecGx LLCWebster Groves, MO 63119 USA Rev 08/2017 Mallinckrodt™ Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in tight container (USP) with a child-resistant closure.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo, and other brands are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured by:Patheon Inc.Whitby, Ontario, CanadaL1N 5Z5Manufactured for:SpecGx LLCWebster Groves, MO 63119 USA Rev 08/2017 Mallinckrodt™ Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in tight container (USP) with a child-resistant closure.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo, and other brands are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured by:Patheon Inc.Whitby, Ontario, CanadaL1N 5Z5Manufactured for:SpecGx LLCWebster Groves, MO 63119 USA Rev 08/2017 Mallinckrodt™ Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in tight container (USP) with a child-resistant closure.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo, and other brands are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured by:Patheon Inc.Whitby, Ontario, CanadaL1N 5Z5Manufactured for:SpecGx LLCWebster Groves, MO 63119 USA Rev 08/2017 Mallinckrodt™ Pamelor™ (nortriptyline HCl) Capsules USPPamelor™ (nortriptyline HCl) Capsules USP, equivalent to 10 mg, 25 mg, 50 mg, and 75 mg base, are available as follows:10 mg: Light orange opaque cap printed “PAMELOR 10 mg” in black and white opaque body printed “” in black. Bottles of 30..................NDC 0406-9910-0325 mg: Light orange opaque cap printed “PAMELOR 25 mg” in black and white opaque body printed ““ in black. Bottles of 30..................NDC 0406-9911-0350 mg: White opaque cap printed “PAMELOR 50 mg” in black and white opaque body printed “” in black. Bottles of 30..................NDC 0406-9912-0375 mg: Light orange opaque cap printed “PAMELOR 75 mg” in black and light orange opaque body printed “” in black. Bottles of 30..................NDC 0406-9913-03Pamelor™ (nortriptyline HCl) Capsules USPPamelor™ (nortriptyline HCl) Capsules USP, equivalent to 10 mg, 25 mg, 50 mg, and 75 mg base, are available as follows:10 mg: Light orange opaque cap printed “PAMELOR 10 mg” in black and white opaque body printed “” in black. Bottles of 30..................NDC 0406-9910-0325 mg: Light orange opaque cap printed “PAMELOR 25 mg” in black and white opaque body printed ““ in black. Bottles of 30..................NDC 0406-9911-0350 mg: White opaque cap printed “PAMELOR 50 mg” in black and white opaque body printed “” in black. Bottles of 30..................NDC 0406-9912-0375 mg: Light orange opaque cap printed “PAMELOR 75 mg” in black and light orange opaque body printed “” in black. Bottles of 30..................NDC 0406-9913-03Pamelor™ (nortriptyline HCl) Capsules USPPamelor™ (nortriptyline HCl) Capsules USP, equivalent to 10 mg, 25 mg, 50 mg, and 75 mg base, are available as follows:10 mg: Light orange opaque cap printed “PAMELOR 10 mg” in black and white opaque body printed “” in black. Bottles of 30..................NDC 0406-9910-0325 mg: Light orange opaque cap printed “PAMELOR 25 mg” in black and white opaque body printed ““ in black. Bottles of 30..................NDC 0406-9911-0350 mg: White opaque cap printed “PAMELOR 50 mg” in black and white opaque body printed “” in black. Bottles of 30..................NDC 0406-9912-0375 mg: Light orange opaque cap printed “PAMELOR 75 mg” in black and light orange opaque body printed “” in black. Bottles of 30..................NDC 0406-9913-03Pamelor™ (nortriptyline HCl) Capsules USPPamelor™ (nortriptyline HCl) Capsules USP, equivalent to 10 mg, 25 mg, 50 mg, and 75 mg base, are available as follows:10 mg: Light orange opaque cap printed “PAMELOR 10 mg” in black and white opaque body printed “” in black. Bottles of 30..................NDC 0406-9910-0325 mg: Light orange opaque cap printed “PAMELOR 25 mg” in black and white opaque body printed ““ in black. Bottles of 30..................NDC 0406-9911-0350 mg: White opaque cap printed “PAMELOR 50 mg” in black and white opaque body printed “” in black. Bottles of 30..................NDC 0406-9912-0375 mg: Light orange opaque cap printed “PAMELOR 75 mg” in black and light orange opaque body printed “” in black. Bottles of 30..................NDC 0406-9913-03Pamelor™ (nortriptyline HCl) Capsules USPPamelor™ (nortriptyline HCl) Capsules USP, equivalent to 10 mg, 25 mg, 50 mg, and 75 mg base, are available as follows:10 mg: Light orange opaque cap printed “PAMELOR 10 mg” in black and white opaque body printed “” in black. Bottles of 30..................NDC 0406-9910-0325 mg: Light orange opaque cap printed “PAMELOR 25 mg” in black and white opaque body printed ““ in black. Bottles of 30..................NDC 0406-9911-0350 mg: White opaque cap printed “PAMELOR 50 mg” in black and white opaque body printed “” in black. Bottles of 30..................NDC 0406-9912-0375 mg: Light orange opaque cap printed “PAMELOR 75 mg” in black and light orange opaque body printed “” in black. Bottles of 30..................NDC 0406-9913-03Pamelor™ (nortriptyline HCl) Capsules USPPamelor™ (nortriptyline HCl) Capsules USP, equivalent to 10 mg, 25 mg, 50 mg, and 75 mg base, are available as follows:10 mg: Light orange opaque cap printed “PAMELOR 10 mg” in black and white opaque body printed “” in black. Bottles of 30..................NDC 0406-9910-0325 mg: Light orange opaque cap printed “PAMELOR 25 mg” in black and white opaque body printed ““ in black. Bottles of 30..................NDC 0406-9911-0350 mg: White opaque cap printed “PAMELOR 50 mg” in black and white opaque body printed “” in black. Bottles of 30..................NDC 0406-9912-0375 mg: Light orange opaque cap printed “PAMELOR 75 mg” in black and light orange opaque body printed “” in black. Bottles of 30..................NDC 0406-9913-03Pamelor™ (nortriptyline HCl) Capsules USPPamelor™ (nortriptyline HCl) Capsules USP, equivalent to 10 mg, 25 mg, 50 mg, and 75 mg base, are available as follows:10 mg: Light orange opaque cap printed “PAMELOR 10 mg” in black and white opaque body printed “” in black. Bottles of 30..................NDC 0406-9910-0325 mg: Light orange opaque cap printed “PAMELOR 25 mg” in black and white opaque body printed ““ in black. Bottles of 30..................NDC 0406-9911-0350 mg: White opaque cap printed “PAMELOR 50 mg” in black and white opaque body printed “” in black. Bottles of 30..................NDC 0406-9912-0375 mg: Light orange opaque cap printed “PAMELOR 75 mg” in black and light orange opaque body printed “” in black. Bottles of 30..................NDC 0406-9913-03Pamelor™ (nortriptyline HCl) Capsules USPPamelor™ (nortriptyline HCl) Capsules USP, equivalent to 10 mg, 25 mg, 50 mg, and 75 mg base, are available as follows:10 mg: Light orange opaque cap printed “PAMELOR 10 mg” in black and white opaque body printed “” in black. Bottles of 30..................NDC 0406-9910-0325 mg: Light orange opaque cap printed “PAMELOR 25 mg” in black and white opaque body printed ““ in black. Bottles of 30..................NDC 0406-9911-0350 mg: White opaque cap printed “PAMELOR 50 mg” in black and white opaque body printed “” in black. Bottles of 30..................NDC 0406-9912-0375 mg: Light orange opaque cap printed “PAMELOR 75 mg” in black and light orange opaque body printed “” in black. Bottles of 30..................NDC 0406-9913-03Pamelor™ (nortriptyline HCl) Capsules USPPamelor™ (nortriptyline HCl) Capsules USP, equivalent to 10 mg, 25 mg, 50 mg, and 75 mg base, are available as follows:10 mg: Light orange opaque cap printed “PAMELOR 10 mg” in black and white opaque body printed “” in black. Bottles of 30..................NDC 0406-9910-0325 mg: Light orange opaque cap printed “PAMELOR 25 mg” in black and white opaque body printed ““ in black. Bottles of 30..................NDC 0406-9911-0350 mg: White opaque cap printed “PAMELOR 50 mg” in black and white opaque body printed “” in black. Bottles of 30..................NDC 0406-9912-0375 mg: Light orange opaque cap printed “PAMELOR 75 mg” in black and light orange opaque body printed “” in black. Bottles of 30..................NDC 0406-9913-03Pamelor™ (nortriptyline HCl) Capsules USPPamelor™ (nortriptyline HCl) Capsules USP, equivalent to 10 mg, 25 mg, 50 mg, and 75 mg base, are available as follows:10 mg: Light orange opaque cap printed “PAMELOR 10 mg” in black and white opaque body printed “” in black. Bottles of 30..................NDC 0406-9910-0325 mg: Light orange opaque cap printed “PAMELOR 25 mg” in black and white opaque body printed ““ in black. Bottles of 30..................NDC 0406-9911-0350 mg: White opaque cap printed “PAMELOR 50 mg” in black and white opaque body printed “” in black. Bottles of 30..................NDC 0406-9912-0375 mg: Light orange opaque cap printed “PAMELOR 75 mg” in black and light orange opaque body printed “” in black. Bottles of 30..................NDC 0406-9913-03Pamelor™ (nortriptyline HCl) Capsules USPPamelor™ (nortriptyline HCl) Capsules USP, equivalent to 10 mg, 25 mg, 50 mg, and 75 mg base, are available as follows:10 mg: Light orange opaque cap printed “PAMELOR 10 mg” in black and white opaque body printed “” in black. Bottles of 30..................NDC 0406-9910-0325 mg: Light orange opaque cap printed “PAMELOR 25 mg” in black and white opaque body printed ““ in black. Bottles of 30..................NDC 0406-9911-0350 mg: White opaque cap printed “PAMELOR 50 mg” in black and white opaque body printed “” in black. Bottles of 30..................NDC 0406-9912-0375 mg: Light orange opaque cap printed “PAMELOR 75 mg” in black and light orange opaque body printed “” in black. Bottles of 30..................NDC 0406-9913-03
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The mechanism of mood elevation by tricyclic antidepressants is at present unknown. Pamelor is not a monoamine oxidase inhibitor. It inhibits the activity of such diverse agents as histamine, 5-hydroxytryptamine, and acetylcholine. It increases the pressor effect of norepinephrine but blocks the pressor response of phenethylamine. Studies suggest that Pamelor interferes with the transport, release, and storage of catecholamines. Operant conditioning techniques in rats and pigeons suggest that Pamelor has a combination of stimulant and depressant properties.
Non-Clinical Toxicology
Monoamine Oxidase Inhibitors (MAOIs)The use of MAOIs intended to treat psychiatric disorders with Pamelor or within 14 days of stopping treatment with Pamelor is contraindicated because of an increased risk of serotonin syndrome. The use of Pamelor within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated ( ).
Starting Pamelor in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome ( ).
Hypersensitivity to Tricyclic Antidepressants
Cross-sensitivity between Pamelor and other dibenzazepines is a possibility.
Myocardial Infarction
Pamelor is contraindicated during the acute recovery period after myocardial infarction.
Administration of reserpine during therapy with a tricyclic antidepressant has been shown to produce a “stimulating” effect in some depressed patients.
Close supervision and careful adjustment of the dosage are required when Pamelor is used with other anticholinergic drugs and sympathomimetic drugs.
Concurrent administration of cimetidine and tricyclic antidepressants can produce clinically significant increases in the plasma concentrations of the tricyclic antidepressant. The patient should be informed that the response to alcohol may be exaggerated.
A case of significant hypoglycemia has been reported in a type II diabetic patient maintained on chlorpropamide (250 mg/day), after the addition of nortriptyline (125 mg/day).
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with nortriptyline hydrochloride and should counsel them in its appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions” is available for nortriptyline hydrochloride. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking nortriptyline hydrochloride.
Note –
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).